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Safety and Pharmacokinetic Characteristics of DP-R206(Vitamin D3) in Healthy Adult Volunteers

NCT ID: NCT01577849

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to compare the pharmacokinetic characteristics of DP-R206 (150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Vitamin D3 (24,000 IU Vitamin D3 , qd) after oral administration in healthy adult volunteers.

Detailed Description

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The number of patient is thirty-six. Patients were randomly assigned either a Vitamin D3 tablet(24,000 IU Vitamin D3, qd) first, DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) Second or DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) first, Vitamin D3 tablet(24,000 IU Vitamin D3 , qd) second.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Vitamin D3

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

administration of Vitamin D3 24,000 IU

DP-R206

Group Type EXPERIMENTAL

DP-R206

Intervention Type DRUG

administration of DP-R206 (150mg ibandronate / 24,000IU Vitamin D3)

Interventions

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Vitamin D3

administration of Vitamin D3 24,000 IU

Intervention Type DRUG

DP-R206

administration of DP-R206 (150mg ibandronate / 24,000IU Vitamin D3)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 20 to 55 years of healthy volunteers

Exclusion Criteria

* Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alvogen Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Gul KIM, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Chonbuk national University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

References

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Jeon JY, Lee SY, Im YJ, Kim EY, Kim Y, Park TS, Chae SW, Lee JW, Jun H, Lee TW, Kim MG. Comparison of the pharmacokinetics, safety, and tolerability of vitamin D3 in DP-R206 (150-mg ibandronate/24,000-IU vitamin D3 tablet) and as monotherapy (24,000 iu) in healthy male Korean adults. Clin Ther. 2014 Jan 1;36(1):48-57. doi: 10.1016/j.clinthera.2013.12.001. Epub 2013 Dec 28.

Reference Type DERIVED
PMID: 24378207 (View on PubMed)

Other Identifiers

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DP-CTR206-02

Identifier Type: -

Identifier Source: org_study_id